European Regulatory Roundup, October 2021: IVDR Grace Period Proposals And Classification News

The introduction of a series of new grace periods for products falling under the IVD Regulation have dominated October’s EU regulatory news. But that is not the only big news this month.

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While October’s news was dominated by the European Commission’s proposed new transition periods for products falling under the IVD Regulation, this was among several key developments that happened during the month related to the implementation of the new Medical Device and IVD Regulations.

There have also been critical developments related to the medtech industry’s most important standards, to the Eudamed medical device database and to the classification of medical devices.

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